investigation of long-term effects of carelesstm on microcirculation

Conditions: Disorder of Circulatory System; Metabolic Disease

Summary: aim of the study is to investigate long-term effects of carelesstm, a mangifera indica fruit powder on microcirculation and endothelial function after supplementation of 4 weeks. effects will be investigated with 100mg and 300mg carelesstm and compared to placebo.

aim of the study is to investigate long-term effects of carelesstm, a mangifera indica fruit powder on microcirculation and endothelial function after supplementation of 4 weeks. effects will be investigated with 100mg and 300mg carelesstm and compared to placebo. to describe targeted parameter, cutaneous microcirculation will be measured at 1 mm depth as well as flow mediated endothelial function at the beginning and end of supplementation, each. furthermore, the parameters will be determined postprandially 1 hour after glucose loading. additionally the influence on the glucose metabolism, as well as on body weight and body fat will be documented.

Eligibility criteria:
inclusion criteria: * healthy volunteers * men and postmenopausal women * homa index ≥2 and \<5 * bmi: 19 - 30 kg/m2 * age ≥ 40 and ≤ 70 years * nonsmoker * written consent to participate in the study * able and willing to follow the study protocol procedures exclusion criteria: * relevant history, presence of any medical disorder or chronic intake of medication/dietary sup-plements (e.g. polyphenols, l-arginine, niacin, medication of haemodilution, blood flow stimu-lating products like aspirin (acetylsalicylsäure), clopidogrel (adenosin-diphosphat(adp)-inhibitors), glykoprotein-iib/iiia-inhibitors, heparin, marcumar (vitamin k antagonists); dabiga-tran (faktor iia synthese inhibitors) rivaroxaban (faktor xa antagonist), statins) potentially in-terfering with this study at screening. * for this study clinically relevant abnormal laboratory, vital signs or physical findings at screening * diabetes * atopic dermatitis or affected skin at the forearm * injury on the finger, influencing the endopattm measurement * regular consumption of caffeine \> 275 mg (equivalent to 3-4 cups of coffee or 9 cups of black tea) * change of dietary habits within the 2 weeks prior to screening (for instance start of a diet high in vegetables and fruits (≥ 5 portions per day)) * diet high in vegetables and fruits ≥ 5 portions per day * participants anticipating a change in their lifestyle or physical activity levels during the study. * subjects not willing to avoid polyphenol rich foods and abstain from beverages containing caf-feine the day prior to visit 1 and 2. * subjects not willing to abstain from intake of analgesic medication (e.g. aspirin) 24 hours prior to and during visit 1 and 2. * sunbathing or the use of sun-beds 2 weeks prior to study days * subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study. * known hypersensitivity to the study preparation or to single ingredients * pregnant subject or subject planning to become pregnant during the study; breast-feeding sub-ject. * known hiv-infection * known acute or chronic hepatitis b and c infection * blood donation within 4 weeks prior to visit 1 or during the study. * subject involved in any clinical or food study within the preceding month